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A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment

NCT01713426 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2018-04-23

No results posted yet for this study

Summary

This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of these treatments and the duration of the study will be about 10 weeks (assuming that from screening to treatment allocation takes 2 weeks). Participants will be asked to complete questionnaires about various aspects relating to their condition throughout the study.

This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.

Conditions

  • Non-diabetic Painful Peripheral Polyneuropathy
  • Postherpetic Neuralgia (PHN)
  • Peripheral Nerve Injury (PNI)

Interventions

DRUG

Qutenza

Cutaneous patch

DRUG

Pregabalin

Oral capsule

Sponsors & Collaborators

  • Astellas Pharma Europe Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Study Manager · Astellas Pharma Europe Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-11
Primary Completion
2013-09-26
Completion
2013-09-26

Countries

  • Armenia
  • Austria
  • Belarus
  • Belgium
  • Bulgaria
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01713426 on ClinicalTrials.gov